Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Phase 4TerminatedNCT01153061

University of Sao Paulo4 enrolled

Overview

Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Tracheo-esophageal Fistula

Interventions

Fistula closure with Gore Helex Septal OccluderDEVICE

The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures

Gore Helex Septal OccluderDEVICE

Fistula closure with endoscopic release of occluder in the fistula traject.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 14 years old * Benign tracheoesophageal fistulas identified through bronchoscopy; Exclusion Criteria: * Malign neoplasia * Current mechanical ventilation * Immunosuppressed * Current local inflammatory process at fistulas borders * Other clinical risk factors

Locations (1)

Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder

The closure will be confirmed by endoscopic or bronchoscopic observation of the fistula at regular intervals: one week, two weeks, and four weeks after implant of the occluder. A thorax CT scan will ascertain correct positioning and stability of the occluder.

Time frame: 6 months

Data from ClinicalTrials.gov

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